Anterior Cruciate Ligament ReconstructionNCT03551678
Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
A study testing Active feedback gait retraining in people with Anterior Cruciate Ligament Reconstruction, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
The purpose of this study is to determine changes to knee joint loading, biological markers, and cartilage structure following a novel active feedback gait retraining program in anterior cruciate ligament reconstructed patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Active feedback gait retraining
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-40 years
- history of primary ACLR with or without meniscal repair
- full weight-bearing status
- neutral to varus knee alignment
- plans to remain in the area for at least 8 months.
Who cannot join
- Kellgren-Lawrence (KL) radiographic grade > 2
- additional injury or surgery to the involved knee
- BMI >30 kg/m2
- use of walking, orthopedic, or prosthetic assistive device
- pregnancy
- inability to have MRI
Trial locations and contacts
1 site in 1 country.
Jessica Asay, MS contact
United States1 site, 1 recruiting
- Recruiting
VA Palo Alto
Palo Alto, California, 94304
Constance R Chu, MD, 650-721-7618, chucr@stanford.edu
About this study
Official title: Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
The purpose of this study is to determine changes to knee joint loading, biological markers, and cartilage structure following a novel active feedback gait retraining program in anterior cruciate ligament reconstructed patients.
- Being tested
- Active feedback gait retraining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active feedback gait retrainingDevice
The device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Gait retraining | Experimental | Eight weeks of active-feedback gait retraining. The gait retraining device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity. Receives: Device: Active feedback gait retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Adduction Moment
Knee Joint Loading (%Bw*Ht) will be assessed at baseline and immediately after gait retraining
Measured: Change from baseline to immediately after 8 weeks of retraining
Secondary outcomes (4)
Medial knee compartment qMRI
Changes to quantitative MRI measures at 6 months after retraining will be correlated with changes to joint loading
Measured: Change from baseline to 6 months after retraining
Knee Adduction Moment
Knee Joint Loading (%Bw*Ht)
Measured: Change from baseline to 3 months after retraining
Knee Adduction Moment
Knee Joint Loading (%Bw*Ht)
Measured: Change from baseline to 6 months after retraining
Serum inflammatory markers
Changes to serum inflammatory markers immediately after the end of training from baseline will be correlated with changes to joint loading
Measured: Change from baseline to immediately after 8 weeks of retraining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start21 Jun 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Constance Chu, MD, VA Palo Alto Health Care System
- Investigators
- Constance Chu, MD, Principal investigator, VAPAHCS and Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551678
- Sponsor's protocol ID
- 46025
- Other IDs
- CDMRP-PR171647
- Status last verified
- Oct 2020
- First submitted
- 29 May 2018
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA): Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk
- ClinicalTrials.gov ID
- NCT03551678
- Acronym / sponsor ID
- 46025
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine changes to knee joint loading, biological markers, and cartilage structure following a novel active feedback gait retraining program in anterior cruciate ligament reconstructed patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait retraining | Experimental | Device: Active feedback gait retrainingEight weeks of active-feedback gait retraining. The gait retraining device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 18-40 years
- history of primary ACLR with or without meniscal repair
- full weight-bearing status
- neutral to varus knee alignment
- plans to remain in the area for at least 8 months.
Key exclusion criteria (6 listed)
- Kellgren-Lawrence (KL) radiographic grade > 2
- additional injury or surgery to the involved knee
- BMI >30 kg/m2
- use of walking, orthopedic, or prosthetic assistive device
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active feedback gait retrainingThe device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity. | Device | Gait retraining |
Primary outcome
Knee Adduction Moment
Time frame: Change from baseline to immediately after 8 weeks of retraining
Knee Joint Loading (%Bw*Ht) will be assessed at baseline and immediately after gait retraining
4 secondary outcomes
Medial knee compartment qMRI
Time frame: Change from baseline to 6 months after retraining
Knee Adduction Moment
Time frame: Change from baseline to 3 months after retraining
Knee Adduction Moment
Time frame: Change from baseline to 6 months after retraining
Serum inflammatory markers
Time frame: Change from baseline to immediately after 8 weeks of retraining
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Reconstruction
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Asay, MS contact
Constance Chu, MD principal investigator
VAPAHCS and Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active feedback gait retraining in people with Anterior Cruciate Ligament Reconstruction, run by VA Palo Alto Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Hledik, PhD (650-493-5000 ext. 62388, jerhart@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Adduction Moment (time frame: Change from baseline to immediately after 8 weeks of retraining). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.